The production and distribution of the Top Line Re
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Posted On: 05/19/2021 12:13:26 PM
Re: Goosebumps #90911
The production and distribution of the Top Line Report was a much needed benchmark in my opinion. Pourhassan has said you need to follow the process - well, producing the Top Line Report was part of the process. And as all can see, the numbers changed a little.
An executive summary, released in the form of an 8K ,was just not good enough in my estimation. If CD12 numbers are referenced now, they have to come from the report or it has to be explained why not.
In the statement on Leronlimab by the FDA, it looked like the FDA was using their own numbers from their preliminary peek at the data and I think they were wrong!
Now the correct numbers are being distributed to the USFDA and other countries' FDAs in an official form. We may find that some FDA may say those numbers are good enough for them. At least for an EUA.
Let's see if other FDAs find that "the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19." The FDA statement was written before the release of the Top Line Report and is much too categorical in its judgements.
We missed some p values! Absolutely doesn't mean Leronlimab doesn't work! Stupid!
Read More: https://investorshangout.com/messages/view?id...z6vKOZQ8Rc
An executive summary, released in the form of an 8K ,was just not good enough in my estimation. If CD12 numbers are referenced now, they have to come from the report or it has to be explained why not.
In the statement on Leronlimab by the FDA, it looked like the FDA was using their own numbers from their preliminary peek at the data and I think they were wrong!
Now the correct numbers are being distributed to the USFDA and other countries' FDAs in an official form. We may find that some FDA may say those numbers are good enough for them. At least for an EUA.
Let's see if other FDAs find that "the data currently available do not support the clinical benefit of leronlimab for the treatment of COVID-19." The FDA statement was written before the release of the Top Line Report and is much too categorical in its judgements.
We missed some p values! Absolutely doesn't mean Leronlimab doesn't work! Stupid!
Read More: https://investorshangout.com/messages/view?id...z6vKOZQ8Rc
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